Vedolizumab, Anti-CD25 Antibody Combined With Rapid Reduction of Glucocorticoids as Treatment of Grade 3-4 Steroid-resistant Acute Graft-versus-host Disease With Lower Gastrointestinal Involvement

GVHD002

Acute graft-versus-host disease (aGVHD) is the most common life-threatening complication of allogeneic hematopoietic stem cell transplantation. The investigators try to observe the efficacy and safety of application of vedolizumab, anti-CD25 monoclonal antibody and rapid reduction of glucocorticoids in the treatment of grade 3-4 steroid-refractory aGVHD(SR-aGVHD) with lower gastrointestinal involvement.

2022-08-01

2025-07-31

2025-12-31

Recruiting

Early phase I

45

Inclusion Criteria: * Clinical diagnosis of grade 3-4(according to MAGIC criteria) steroid-resistant acute graft-versus-host disease(progression after 3 days or lack of improvement after 5 days of systemic 1.5-2 mg/kg steroids) with gastrointestinal involvement. * Age 18-65. * ECOG score≤3. * Must be able to understand and willing to participate in the study and sign the informed consent. Exclusion Criteria: * Refractory/secondary graft-versus-host disease. * Severe complications such as myocardial infarction, chronic cardiac insufficiency, * hepatic failure, renal insufficiency, etc. * Clinically uncontrolled active infections. * Other Malignant tumors with progression. * Heart failure: EF\<30%, NYHA≥grade III. * Pregnant or lactating women. * Expected survival \<60 days. * Undergoing other drug clinical trials.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}

2023-10-04